Manager, QA Compliance

Job Responsibilities

• Support the company’s short- and long-term goals for regulatory, ISO, and global compliance
• Assist the Senior Manager with supplier management, internal audit, and quality agreement programs
• Coordinate and facilitate supplier management activities and support qualification of new and existing suppliers
• Assist with the annual external audit plan with Global Procurement
• Coordinate, perform, and assist with supplier qualification and requalification activities
• Coordinate and maintain the Approved Vendor List
• Support local, regional, and global departments with supplier-related questions and requests
• Perform or assist with supplier risk assessments for non-compliance inspection outcomes
• Collaborate with cross-functional groups on supplier requalification activities
• Interface with suppliers for on-site, virtual, hybrid, or document audits and request qualification documentation
• Perform supplier requalification audits as needed
• Collect and review supplier qualification documentation
• Prepare supplier requalification and assessment/evaluation reports
• Maintain regional and global supplier tracking databases
• Investigate supplier change notifications in Kabi Track through closure
• Coordinate and facilitate the regional internal audit program
• Perform annual risk assessments for the internal audit plan
• Ensure internal audits are scheduled, conducted, and closed
• Participate in internal audits as Lead or Co-auditor
• Plan, prepare, and conduct internal audits
• Draft audit reports, review CAPA plans, and issue audit closures
• Interface with auditees and maintain the internal audit tracking database
• Coordinate and manage Global Procurement Quality Agreement database updates and reviews
• Coordinate and perform regional periodic reviews of Quality Agreements
• Coordinate, negotiate, and support supplier and inter-company Quality Agreements
• Collaborate with cross-functional groups and suppliers to draft, review, and finalize Quality Agreements
• Assist with monthly management review presentations
• Coordinate monthly supplier data for product APQR
• Assist with Implementation Assessments for Global QM Documents
• Provide and support Annual Supplier Evaluations
• Support internal, external, customer, and regulatory inspections
• Maintain and improve supplier management, internal audit, and quality agreement programs
• Act as backup for the Senior Manager with support from the VP, NAM Quality

• Bachelor's degree in the sciences
• 8+ years of progressive challenging QA/QC experience in pharmaceutical or related regulated industry
• In-depth knowledge of current GMP and related quality systems
• Strong leadership, communication, interpersonal, negotiation, and problem resolution skills
• Organized, detail-oriented, and able to handle multiple tasks and redirect focus based on company needs
• Able to function independently with minimal supervision
• Effective ability to speak, read, write, and understand English
• Applicants must be authorized to work for any employer in the United States;
  Fresenius Kabi cannot sponsor or take over sponsorship of an employment visa now or in the future

Demonstrates extensive experience in Quality Assurance and Quality Control within regulated industries, with a strong focus on supplier management, internal audits, and compliance with GMP standards. Proficient in coordinating supplier qualifications, conducting audits, and maintaining quality agreement programs.

• Quality Assurance Management
• Supplier Qualification
• Internal Auditing
• GMP Compliance
• Regulatory Inspections

• Quality Management Systems
• Supplier Risk Assessment
• Audit Report Drafting
• CAPA Plans
• Supplier Tracking Databases
• Quality Agreement Negotiation
• Regulatory Compliance
• Supplier Management Programs
• GMP Knowledge
• Data Analysis

• Leadership
• Communication
• Interpersonal Skills
• Negotiation
• Problem Resolution

• Pharmaceutical Industry
• Regulated Industry
• ISO Compliance
• Internal Audit
• Supplier Management

• Kabi Track
• Audit Tracking Database
• Supplier Management Software